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Multiply Labs is revolutionizing cell therapy production with ai

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins.

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins, cutting costs by up to 70%, increasing throughput, and reducing contamination ri

The Biotech Times Editorial Team  · 
Pharmaceuticals

Orion Pharma's ODM-212 wins EU Orphan Designation for mesothelioma

The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biotech

Parabilis Medicines raises $745m in upsized Nasdaq IPO

The Cambridge biotech priced 33.5 million shares at $20 each, with Regeneron taking a concurrent $75m private placement stake.
The Cambridge biotech priced 33.5 million shares at $20 each, with Regeneron taking a concurrent $75m private placement stake.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Menarini selinexor combo meets spleen endpoint in Phase 3 MF

Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.
Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.
The Biotech Times Editorial Team  · 
Pharmaceuticals

J&J talquetamab plus daratumumab cuts RRMM death risk by up to 53%

Phase 3 MonumenTAL-3 data show talquetamab combinations beat standard care on PFS and OS in earlier-line relapsed myeloma.
Phase 3 MonumenTAL-3 data show talquetamab combinations beat standard care on PFS and OS in earlier-line relapsed myeloma.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

HUTCHMED sovleplenib hits Phase III primary endpoint in wAIHA

ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Novo Nordisk wins MHRA approval for oral Wegovy semaglutide pill

The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The Biotech Times Editorial Team  · 
Pharmaceuticals

Sanofi halts MOBILIZE Phase 3 trial of riliprubart in refractory CIDP

An independent data monitoring committee found the study unlikely to demonstrate sufficient efficacy; no safety concerns were identified with riliprubart.
An independent data monitoring committee found the study unlikely to demonstrate sufficient efficacy; no safety concerns were identified with riliprubart.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Kymera Therapeutics doses first participant in IRAK4 degrader trial

KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Imviva Biotech wins FDA IND clearance for dual-target allogeneic CAR-T

CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Chiesi wins Health Canada priority review for FILSUVEZ in EB

Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.
Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.
The Biotech Times Editorial Team  · 
Pharmaceuticals

SERB Pharmaceuticals buys European and MENA rights to Idefirix for €115m

SERB Pharmaceuticals will acquire imlifidase's European and MENA commercialisation rights from Hansa Biopharma, targeting highly sensitised kidney transplant patients.
SERB Pharmaceuticals will acquire imlifidase's European and MENA commercialisation rights from Hansa Biopharma, targeting highly sensitised kidney transplant patients.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Roche and Nurix strike $2.3bn BTK degrader deal for bexobrutideg

Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

GH Research publishes Phase 2a PPD data for inhaled GH001

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
The Biotech Times Editorial Team  · 
Pharmaceuticals

BriaCell wins FDA clearance for Bria-BRES+ breast cancer IND

BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biotech

Novo Nordisk raises 2026 guidance as Wegovy pill tops 2m prescriptions

Novo Nordisk lifted its full-year outlook after Wegovy pill surpassed two million prescriptions since its January launch, despite US pricing pressure denting adjusted
Novo Nordisk lifted its full-year outlook after Wegovy pill surpassed two million prescriptions since its January launch, despite US pricing pressure denting adjusted
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Madrigal Pharmaceuticals posts $311m Rezdiffra Q1 sales, up 127%

Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biotech

Electra Therapeutics doses first patient in ipsoprubart T cell trial

Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
The Biotech Times Editorial Team  · 
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